BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISISON SYSTEM OZIL

    MDR report key: 4132662 · Received September 24, 2014

    Report

    Report Number
    2028159-2014-01768
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AFTER UNDERGOING AN UNEVENTFUL PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED DISTURBANCE IN THE LEFT EYE, AND SOUGHT EMERGENCY SERVICE THREE DAYS AFTER SURGERY. THE PATIENT PRESENTED THE CORNEAL EDEMA, CORNEAL INFILTRATES, AND HYPOPYON. THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS AND WAS TREATED WITH INTRAVITREAL ANTIBIOTICS FOR TWO DAYS, HOWEVER THE RESPONSE WAS UNFAVORABLE, THE PATIENT WAS THEN SENT TO ANOTHER HOSPITAL WHERE AN EYE CULTURE WAS PERFORMED. THE IOL (INTRAOCULAR LENS) IMPLANT WAS EXPLANTED AND VITRECTOMY WAS PERFORMED, HOWEVER THE YES WAS ULTIMATELY ENUCLEATED. THE REPORTER DID NOT KNOW WHAT CAUSED THE ENDOPHTHALMITIS. IT WAS NOTED THAT THE SINGLE USE I/A (IRRIGATION/ASPIRATION) TIP HAD MORE THAN ONE YEAR OF USE. THIS IS THE FIRST OF TWO REPORT FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595988 INFINITI VISISON SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Disability MIOSTAT| ZYMAR| A-OK 15D FULL HANDLE 1.52MM| NEVANAC| I/A (IRRIGATION/ASPIRATION) TIP| 45KT| TS TIP| INTREPID PLUS PAK 0.9MM ULTRA| INFINITI PHACO HANDPIECE| IOL INJECTOR| SIMCOE CANNULA| MONARCH III "D" CARTRIDGE| ANESTALCON| PRED FORTE| VIAGAMOX| DUOVISC| BSS (BALANCED SALT SOLUTION)| MINI FLAIR AB 0.9MM| SN60WF ACRYSOF SP NATURAL IQ LENS| EYE-PAK DRAP BLUE NW FABRIC